Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma

NCT01731886 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: AAAJ2355
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.

Conditions

Multiple Myeloma

Keywords

Stem cell transplant; plasma cell myeloma; multiple myeloma

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate

  The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).

  3 years

Secondary Outcomes (4)

• Overall Survival Rate (OS)

  4 years

• Overall Survival Rate (OS)

  2 years

• Progression Free Survival (PFS)

  4 years

• Progression Free Survival (PFS)

  2 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).

Procedure: Autologous peripheral blood stem cell transplant; Drug: Lenalidomide; Drug: Dexamethasone; Procedure: Stem cell collection; Drug: Melphalan; Drug: G-CSF; Drug: Cyclophosphamide; Drug: Mesna

Arm B

ACTIVE COMPARATOR

Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).

Drug: Lenalidomide; Drug: Dexamethasone; Procedure: Stem cell collection; Drug: Cyclophosphamide; Drug: Mesna

Interventions

Autologous peripheral blood stem cell transplant PROCEDURE

Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.

Arm A

Lenalidomide DRUG

Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.

Also known as: CC-5013, Revlimid

Arm A; Arm B

Dexamethasone DRUG

Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.

Also known as: Decadron, Hexadrol, Dexameth, Dexone, DXM

Arm A; Arm B

Stem cell collection PROCEDURE

Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3.

Also known as: Stem Cell Mobilization

Arm A; Arm B

Melphalan DRUG

Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.

Also known as: Evomela

Arm A

G-CSF DRUG

Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.

Also known as: Granulocyte-colony stimulating factor (CSF), Filgrastim

Arm A

Cyclophosphamide DRUG

Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.

Also known as: Cytophosphane

Arm A; Arm B

Mesna DRUG

Mesna will be provided with the cyclophosphamide.

Also known as: Mesnex

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or III or International Staging System II or III that has not been previously treated.
• Bone marrow plasmacytosis with \> or = 10% plasma cells, or sheets of plasma cells or a biopsy-proven plasmacytoma.
• Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or \> 200 mg of monoclonal light chain on a 24 hour urine protein electrophoresis.
• Age \> or = 18 years.
• Life expectancy of greater than 12 months.
• Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 (Karnofsky \> or = 60%).
• Adequate organ and marrow function as defined below:
• Hgb \> or = 9 g/dL
• Absolute Neutrophil Count \> or = 1,500/ ml
• Platelets \> or = 50,000/mm3
• Total Bilirubin \< or = 1.5 mg/dL
• Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) \< or = 2.5 X upper limit of normal (ULN)
• Creatinine \< 2.0 mg/dL
• Creatinine Clearance \> or = 50 ml/min
• Registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.

You may not qualify if:

• Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.
• Receiving any other investigational agents or therapy within 28 days of baseline.
• Brain metastases.
• Subjects who are pregnant or breast feeding.
• History of previous deep vein thrombosis or pulmonary embolism must be on anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic dosages (e.g. International Normalized Ratio (INR) 2-3).
• If a subject is on full-dose anticoagulants, the following criteria should be met for enrollment:
• Must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices).
• Must not have thrombocytopenia requiring transfusion.
• Must have a platelet count \> 50,000.
• Must have stable INR between 2-3.
• Smoldering myeloma or monoclonal gammopathy of undetermined significance.
• Active, uncontrolled infection.
• Active, uncontrolled seizure disorder (seizures in the last 6 months).
• Concurrent use of other anti-cancer agents or treatments.
• Positive for HIV or infectious hepatitis, type B or C.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Lenalidomide; Dexamethasone; Calcium Dobesilate; Hematopoietic Stem Cell Mobilization; Melphalan; Granulocyte Colony-Stimulating Factor; Filgrastim; Cyclophosphamide; Mesna

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Biological Therapy; Therapeutics; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds

Results Point of Contact

• Title: Suzanne Lentzsch, MD, PhD, Professor of Medicine
• Organization: Columbia University

sl3440@cumc.columbia.edu

646-317-4840

Study Officials

• Suzanne Lentzsch, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Clinical Medicine

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: September 1, 2012
• Primary Completion: April 11, 2017
• Study Completion: April 11, 2017
• Last Updated: February 5, 2020
• Results First Posted: October 15, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study.
• Access Criteria: All data will be coded with study identifiers.

Locations

US (1)